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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K160018
Device Name Arrow Quickflash Arterial Catheterization Device
Applicant
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact TRACY LARISH
Correspondent
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact TRACY LARISH
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/05/2016
Decision Date 06/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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